Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Inclusion Criteria: Main phase (the inclusion criteria for the main phase are not
reassessed for the extension phase): - Informed consent obtained before any trial-related
activities. Trial-related activities are any procedures that are carried out as part of the
trial, including activities to determine suitability for the trial - Male or female, age
above or equal to 18 years at the time of signing informed consent. For Korea only: Male or
female, age above or equal to 19 years at the time of signing informed consent - Diagnosed
with type 2 diabetes mellitus for at least 90 days prior to day of screening - HbA1c
(glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive) - Treatment target of
HbA1c below 7.0% (53 mmol/mol), as judged by the investigator - Stable daily dose(s) of 1-2
of the following anti-diabetic drugs within 90 days prior to the day of screening:-
Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject
medical record) - Sulfonylureas (equal or above half of the maximum approved dose according
to local label or maximum tolerated dose as documented in subject medical record) - Sodium
glucose co-transporter 2 inhibitors - Thiazolidinediones (equal or above half of the
maximum approved dose according to local label or maximum tolerated dose as documented in
subject medical record) Extension phase: - Informed consent for the extension phase
obtained before any trial-related activities for the extension phase. - On randomised
treatment with or without rescue medication at week 52. Exclusion Criteria: Main phase (the
exclusion criteria for the main phase are not reassessed for the extension phase): - Female
who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
potential and not using an adequate contraceptive method (adequate contraceptive measure as
required by local regulation or practice). For certain specific countries: Additional
specific requirements apply - Any disorder, which in the investigator's opinion might
jeopardise subject's safety or compliance with the protocol - Family or personal history of
Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of
pancreatitis (acute or chronic) - History of major surgical procedures involving the
stomach potentially affecting absorption of trial product (e.g. subtotal and total
gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Any of the following: myocardial
infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack
within the past 180 days prior to the day of screening and randomisation - Subjects
presently classified as being in New York Heart Association Class IV - Planned coronary,
carotid or peripheral artery revascularisation known on the day of screening - Subjects
with alanine aminotransferase above 2.5 x upper normal limit - Renal impairment defined as
Estimated Glomerular Filtration rate 60 mL/min/1.73 m^2 as per Chronic Kidney Disease
Epidemiology Collaboration formula - Treatment with any medication for the indication of
diabetes or obesity other than stated in the inclusion criteria in a period of 90 days
before the day of screening. An exception is short-term insulin treatment for acute illness
for a total of below or equal to 14 days - Proliferative retinopathy or maculopathy
requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed
within 90 days prior to randomisation - History or presence of malignant neoplasms within
the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ) -
History of diabetic ketoacidosis Extension phase: There are no new exclusion criteria for
the extension phase